MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUPLOSPRAY APPLICATOR; SYRINGE, PISTON

Lot Number D8U053AC

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  malfunction  

Event Description

Md went to spray the tisseel and it was clogged in the duplosprayer and would not come out.We checked the tisseel sprayer and it was functioning correctly, and gas was full.We had to replace the tisseel medication as well as the duplosprayer which functioned correctly after the fact.Fda safety report id # (b)(4).

• Brand Name: DUPLOSPRAY APPLICATOR
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL 60015
• MDR Report Key: 9540456
• MDR Text Key: 173951469
• Report Number: MW5092000
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Lot Number: D8U053AC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR